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Investigation Instructions

Principal Investigators/Study Coordinators/Regulatory Coordinators:

Welcome to the Centra IRB Web Page!

To the right of the page are forms necessary for approval from the Centra IRB. Below are brief descriptions of the documents.

The Centra Policy and Procedure Manual is revised annually. There are numerous documents: one is with the IRB manual and the rest of the documents are the Appendices.

The IRB meets monthly (usually the 3rd Tuesday of each month). The deadline for applications are due to the IRB secretary 14 days prior to the next meeting. (Example: Meeting is scheduled for Tuesday, February 19; all applications are due by Tuesday, February 5, 5:00 pm.) If the submission does not make this deadline the application will be placed on the next scheduled meeting (Example: Tuesday, March 19.)

Forms can be emailed to the IRB secretary (irb@centrahealth.com). Electronic signature are acceptable.

Appendix C Form 1 is for the initial application. This will need to be completed and any pertinent documents should accompany it when submitted. Pertinent documents include the protocol, Investigators Brochure, Informed Consent Form, survey document, etc. The principal investigator and/or study coordinator will need to attend the initial meeting and present the study to the IRB.

Federal Regulations/Centra IRB Policy and Procedures require at least annual renewal/update by the expiration date. Renewal/update/closure forms will be sent to you prior to the scheduled review.

If you are seeking a waiver of jurisdiction to another IRB of record plese see below.

Appendix D Form 2A 2B is for an annual renewal, update or closure of the study. The principal investigator and/or study coordinator may be required to attend the meeting; however, usually a phone number to contact the PI or SC for any questions is sufficient.

Appendix E Form 3 is for any modification to the study.

Appendix F Form 4 is for quarterly/biannual report required by the IRB.

Appendix G Form 5 is a Waiver of Authorization is for need access to and use only the minimum amount of Protected Health Information (PHI) necessary to review eligibility criteria and contact potential subjects complete this form.

Appendix H Form 6 is a Exempt Research Checklist.  The ERC is to determine if your research requires submission of a full/initial application to Centra IRB.  The IRB Exempt committee will review this application.

Appendix I Form 7 is a HIPAA Authorization.  Each participant will need to sign this form if your study will use Protected Health Information (PHI).

All applications include a Conflict of Interest Disclosure Form.

The IRB secretary's email address is irb@centrahealth.com and the phone number is (434) 200-4513.

We look forward to working with you in your study.

IRB Executive Committee
Matt Johnson, MD, Chair; Michael Judd, MD, Vice Chair; 

Waiver of Jurisdiction

Local investigators may request a waiver of jurisdiction to another IRB. The investigator seeking a waiver should send a letter, or email, to the IRB secretary and should include the following documents:
1.     The application that was made to the IRB providing review
2.     The study protocol
3.     The informed consent
4.     A description of the IRB providing review
Note:  A link to a website is sufficient if it provides enough information for the Centra IRB to evaluate.
5.     An authorization agreement that delineates the responsibilities of each party
 
If the investigator provides the documentation referenced above, a Centra IRB application is not required.
 
The Centra IRB may approve specific reviewing IRBs based on accreditation and other factors. Investigational studies that utilize these IRBs can apply for a waiver of jurisdiction using the expedited review process. If the Chairman and Vice Chairman unanimously approve the request for waiver of jurisdiction in an expedited review, the investigator may proceed without further delay.
 
The Centra IRB will maintain a list of approved IRBs. The Centra IRB may add or delete from the list. The list must be reviewed at least annually.
 
If the IRB providing review does not appear on the approved list, the request must be reviewed by the full board.
Investigators who participate in waived investigations are required to report the following information for each study to the IRB annually:
1.     Annual total and local enrollment (number of subjects enrolled)
2.     Local SAEs reportable to the IRB of record
3.     Local protocol deviations and/or violations reportable to the IRB of record
 
The Centra IRB may approve the use of another IRB in cases where an academic institution allows a local investigator to enroll Centra patients, but will not otherwise provide a reliance agreement to the Centra IRB. This is not a “waived” study per se, and the IRB at the institution has no responsibility to the Centra IRB. However, the local investigator continues to be responsible for reporting to the Centra IRB and the Centra IRB will have the authority to discontinue local enrollment. The local investigator will be required to report the same information as other investigators who report on waived studies.

 

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 Forms

 
  
  
Appendix A OHRP IRB Membership.pdf
  
Appendix B CHIRB Conflicts of Interest Disclosure Form for IRB members V3 25FEB2015.doc
  
Appendix B CHIRB Conflicts of Interest Disclosure Form for IRB members V3 25FEB2015.pdf
  
Appendix C Form 1 Centra IRB Initial Application V12 19DEC2017 .doc
  
Appendix C Form 1 Centra IRB Initial Application V12 19DEC2017 .pdf
  
Appendix D Form 2A 2B Centra IRB Renewal Update or Closure V8 15NOV2016.doc
  
Appendix D Form 2A 2B Centra IRB Renewal Update or Closure V8 15NOV2016.pdf
  
Appendix E Form 3 Centra IRB Modification V6 15NOV2016.doc
  
Appendix E Form 3 Centra IRB Modification V6 15NOV2016.pdf
  
Appendix F Form 4 Centra IRB Report V3 19DEC2017 .doc
  
Appendix F Form 4 Centra IRB Report V3 19DEC2017 .pdf
  
Appendix G Form 5 Centra IRB Waiver of Authorization V4 19DEC2017.doc
  
Appendix G Form 5 Centra IRB Waiver of Authorization V4 19DEC2017.pdf
  
Appendix H Form 6 Centra IRB Exempt Research Checklist V5 19DEC2017.doc
  
Appendix H Form 6 Centra IRB Exempt Research Checklist V5 19DEC2017.pdf
  
Appendix I Form 7 Centra HIPAA Authorization V1 23JUN2015.doc
  
Appendix I Form 7 Centra HIPAA Authorization V1 23JUN2015.pdf
  
Appendix J 21CFR 50.1-56 Protection of Human Subjects Rev 01APR2017.pdf
  
Appendix K 21CFR 56.101-124 Institutional Review Boards Rev 01APR2017.pdf
  
Appendix L 45CFR 46.101-505 Protection of Human Subjects e-Data current as of 15JAN2009.pdf
  
Appendix M Info Sheet Guidance SR and NSR Medical Devices Studies JAN2006.pdf
  
Appendix N AAMC Principles for Protecting Integrity In the Conduct and Reporting Of Clinical Trials.pdf
  
HOW TO CHOOSE THE APPROPRIATE IRB APPLICATION FORM V1 11.07.17.pdf
  
IRB Charter 19DEC2017.pdf
  
IRB policy and procedure manual Version 19DEC2017.pdf